NCT05466994

A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Naïve Undergoing Surgery to Reduce Postoperative Opioid Use (GAMING-ON Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 5 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

To learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients scheduled for surgery.

Detailed description

Primary Objective: •To assess the efficacy of SpellBound's AR-enabled scavenger hunt to reduce the rate of 90-day opioid use in pediatric cancer patients undergoing surgery compared to a control non-AR game in a randomized controlled trial. Secondary Objectives: To assess the effect of AR versus non-AR control technology in pediatric oncology patients, including: * Inpatient opioid use * Average daily inpatient pain score * Number of opioid requests during the hospital stay * Inpatient PedsQL (quality of life) questionnaire score * Ambulation/"out of bed" movement * Number days to discharge-ready status * Patient experience assessed by satisfaction scores on a questionnaire designed by MD Anderson Cancer Center Child Life team. * Outpatient opioid consumption reported at 30, 60, and 90 days * Outpatient pain scores reported at 30, 60, and 90 days * Outpatient PedsQL scores reported at 30, 60, and 90 days * Potential adverse events related to the use of AR (i.e., falls).

Conditions

• Pediatric ALL
• Cancer

Interventions

Type	Name	Description
OTHER	IPAD	Participant will play a game through (standard camera) participants will be able to the hospital room and decals as they appear in the real world
OTHER	Augmented Reality	Participants will play a game through (devices camera and application) let us participants view the real world

Timeline

• Start date: 2022-08-19
• Primary completion: 2026-01-13
• Completion: 2026-01-13
• First posted: 2022-07-20
• Last updated: 2026-01-15

Locations

2 sites across 1 country: United States